Self-Hypnosis Training for Migraine Management (HYlaMI): A Pilot and Proof-of-Concept Study

Официальное название

Self-Hypnosis Training for Migraine Management (HYlaMI): A Pilot and Proof-of-Concept Study of the Intervention Program (ORBIT Phase IIa-IIb)

Обзор

Migraine is one of the most common and disabling neurological conditions worldwide, affecting approximately 1 billion people. Available pharmacological treatments have significant limitations (side effects, contraindications, medication overuse), highlighting the need for effective non-pharmacological alternatives. The HYlaMI program (Self-Hypnosis Training for Migraine Management) is an 8-session group-based telehealth intervention adapted from HYlaDO, a self-hypnosis program developed for chronic pain management at the Hôpital Maisonneuve-Rosemont Pain Clinic (Montréal, Canada). Building on a refinement study conducted in autumn 2025 (CER: 2026-4061), HYlaMI combines heterohypnosis (guided by a trained clinician) and self-hypnosis (practiced autonomously at home using audio recordings) through weekly one-hour video sessions (Zoom/CIUSSS EMTL platform). This study combines ORBIT Phase IIa (proof of concept) and Phase IIb (pilot study) objectives. The primary aims are to evaluate the feasibility of the HYlaMI program (retention and adherence rates) and to assess whether it can generate a clinically significant change in migraine-related disability compared to a waitlist control group. Secondary aims include evaluating effects on anxiety and depressive symptoms, pain self-efficacy, situational pain/anxiety/relaxation, migraine frequency, intensity and duration, medication intake, work absenteeism, quality of life, and the economic burden of migraine. A mixed-methods design will be used. Forty adults with a diagnosis of migraine for more than one year will be randomized to either the HYlaMI intervention group (n=20) or a waitlist control group (n=20). Participants will complete validated questionnaires at multiple time points (pre-intervention, mid-intervention, post-intervention, and 4-week follow-up), a weekly migraine diary, and self-hypnosis practice logs. Two semi-structured focus groups will be conducted with intervention group participants to inform program improvement. If successful, this study will provide the evidence base required to proceed to a larger randomized controlled trial (ORBIT Phase III).

Подробное описание

Background.

Migraine affects approximately 1.04 billion individuals worldwide and is associated with substantial socioeconomic burdens, including reduced quality of life, mental health comorbidities (anxiety, depression), and productivity losses. Non-pharmacological interventions, including clinical hypnosis, represent a growing area of investigation.

Intervention.

The HYlaMI program consists of 8 weekly one-hour group sessions delivered via teleconference (Zoom, CIUSSS EMTL platform). Seven hypnotic exercises are introduced sequentially, each following a standard hypnotic structure (induction, deepening, hypnotic work, post-hypnotic suggestions, return to waking state):

* Session 1: Psychoeducation on medical hypnosis and pain + "Pleasant place" exercise * Session 2: "Backpack" exercise (anxiety and emotion management) * Session 3: "Doing nothing" exercise (pain acceptance, catastrophizing) * Session 4: "Thermal object" exercise (pain perception modification) * Session 5: "Magic hand" exercise (analgesic suggestion) * Session 6: "Rossi method" (resource-based pain relief) * Session 7: "Reconnecting with a resource" (introspection and self-efficacy) * Session 8: Conclusion, self-hypnosis prescription and 30 minutes Focus group on Social Validity of the intervention

A 9th session (1h-Focus group on Self-hypnosis practice+ follow-up meeting) is held 4 weeks post-intervention.

All 7 hypnotic exercises are provided as high-quality audio recordings to enable home self-hypnosis practice between sessions.

Study Design

Mixed-methods pilot and proof-of-concept study with two parallel arms: HYlaMI intervention group and waitlist control group. Randomization is performed using an online random group generator. For ethical reasons, waitlist participants will receive the full intervention after study completion.

Outcome Assessment Schedule

14 measurement time points are planned: T-1 and T0 (pre-intervention baseline), T1-T8 (weekly during intervention), and T9-T12 (weekly post-intervention follow-up).

Hypnotizability

Baseline hypnotizability is assessed using the Harvard Group Scale of Hypnotic Susceptibility, Form A (HGSHS:A), French online version, and will be used as a covariate in all analyses.

Data Management

Electronic questionnaires are managed via REDCap (CIUSSS EMTL server). Paper journals are used for in-session measures. Focus groups are recorded via Zoom, transcribed using OneDrive Word, and analyzed with NVivo 12.

Вмешательства

• Поведенческое HYlaMI (Self-Hypnosis Training for Migraine Management)
  Eight weekly one-hour group telehealth sessions (Zoom/CIUSSS EMTL platform) delivering 7 complementary self-hypnosis exercises targeting migraine-related pain, stress, anxiety, and psychological resources. Each session follows a standardized hypnotic structure. High-quality audio recordings of all exercises are provided to participants for home self-hypnosis practice. A clinician-researcher (doctoral candidate in neuropsychology, trained in hypnosis) leads all sessions using a standardized clini

Первичные конечные точки

• Migraine-related disability - Migraine Disability Assessment (MIDAS) [Срок оценки: One-week-pre-intervention (T0) and 4-week post-intervention follow-up (4-weeks-post-intervention: T12)]
• Migraine-related disability - Headache Impact Test (HIT-6) [Срок оценки: One-week-pre-intervention (T0), mid-intervention (week 4: T4), end of intervention (week 8: T8), and 4-week follow-up (4-weeks-post-intervention: T12)]
• Program feasibility - Retention and adherence rates [Срок оценки: Throughout intervention (first to 8th week of intervention: T1-T8)]

Вторичные конечные точки (12)

• Anxiety and depressive symptoms [Срок оценки: One-week-pre-intervention (T0), mid-intervention (week 4: T4), end of intervention (week 8: T8), and 4-week follow-up (4-weeks-post-intervention: T12)]
• Pain self-efficacy [Срок оценки: One-week-pre-intervention (T0), mid-intervention (week 4: T4), end of intervention (week 8: T8), and 4-week follow-up (4-weeks-post-intervention: T12)]
• Situational pain [Срок оценки: Before and after each hypnosis session (First to 7th week of intervention : T1-T7)]
• Situational anxiety [Срок оценки: Before and after each hypnosis session (First to 7th week of intervention : T1-T7)]
• Situational relaxation [Срок оценки: Before and after each hypnosis session (First to 7th week of intervention: T1-T7)]
• Migraine frequency [Срок оценки: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12 )]
• Measure: Migraine intensity [Срок оценки: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)]
• Migraine duration [Срок оценки: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)]
• Medication intake [Срок оценки: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)]
• Work/school absenteeism [Срок оценки: Weekly (2-weeks-pre-intervention to 4-weeks-post-intervention: T-1 to T12)]
• Quality of life economics [Срок оценки: One-week-pre-intervention (T0), mid-intervention (week 4: T4), end of intervention (week 8: T8), and 4-week follow-up (4-weeks-post-intervention: T12)]
• Economic burden of migraine [Срок оценки: 6th week of intervention and 4-weeks-post-intervention follow-up (T6, T12)]

Критерии участия

Критерии включения

• Formal diagnosis of migraine for more than one year (physician-issued; self-reported diagnosis accepted)
• French-speaking
• No consumption of alcohol or recreational drugs on the morning before group hypnosis sessions (migraine rescue medication is accepted but must be reported if taken before a session)
• Reliable internet connection
• Available to follow the 2.5-month self-hypnosis training program

Критерии исключения

• Sensory or cognitive impairments that would interfere with comprehension (e.g., deafness)
• Severe, unstabilized neurological or psychiatric disorder that impairs communication
• Previous psychological treatment using hypnosis techniques for pain management
• Current participation in another psychological intervention (potential confounder for anxiety/depression outcomes)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• Centre de recherche de l'Hôpital Maisonneuve-Rosemont (CR-HMR) — Montreal

Идентификаторы

NCT: NCT07644299 · CEMTL 2026 4353

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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